Accord Healthcare recalls 10mg BusPIRone Hydrochloride tablets (NDC 16729-202-16) manufactured for FDA inspection deviations. Consumers should contact the manufacturer for details.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 10mg BusPIRone Hydrochloride tablets (500-count bottle) due to FDA inspection findings. This recall follows regulatory deviations in manufacturing processes that could affect product safety.
The recall is triggered by FDA inspection findings indicating manufacturing deviations. These deviations could potentially impact product safety, though specific risks are not detailed in the notice.
Prescription drug users who have the 10mg BusPIRone Hydrochloride tablets (NDC 16729-202-16) from the manufacturer. Patients on specific medication regimens are most at risk.
Check for the 10mg BusPIRone Hydrochloride tablets (500-count bottle) with NDC code 16729-202-16. The product was manufactured by Intas Pharmaceuticals Limited in India and distributed by Accord Healthcare.
Identify the product by checking the NDC code 16729-202-16 on the packaging.
The recall follows FDA inspection findings indicating manufacturing deviations that could affect product safety.
Look for the 10mg BusPIRone Hydrochloride tablets (500-count bottle) with NDC code 16729-202-16.
The official notice does not specify a remedy for this recall.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0378-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0378-2023 from Accord Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
